peppermint oil for the treatment of irritable bowel syndrome: optimizing therapeutic strategies using targeted delivery

Conditions: Irritable Bowel Syndrome; Abdominal Pain; Colonic Diseases, Functional

Summary: peppermint oil has shown to be effective in the treatment of irritable bowel syndrome (ibs) symptoms in several meta-analyses. however, the level of evidence is moderate and peppermint oil remains relatively under-used in ibs. therefore, the investigators will conduct a multicenter randomized, placebo controlled trial to investigate the effects of an eight-week peppermint oil treatment in ibs patients according to current european medicines agency (ema) / us food and drug administration (fda) guidelines. to improve efficacy and to reduce side effects, the investigators aim to study the use of a new peppermint oil formulation, a colon-targeted-delivery capsule that will release the oil in the (ileo-) colonic region specifically.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years; 2. diagnosed with irritable bowel syndrome according to the rome iv criteria: (recurrent abdominal pain, at least 1 day/week for the last 3 months; symptom onset at least 6 months prior to diagnosis; associated with two or more of the following: 1. pain related to defecation; 2. pain associated with a change in frequency of stool; 3. pain associated with a change in form (appearance/consistency) of stool 3. based on the medical history and previous examination, no other causes for the abdominal complaints can be defined. especially no history of: 1. inflammatory bowel disease; 2. celiac disease; 3. thyroid dysfunction (if not well-regulated). if alarm symptoms (including unexplained rectal blood loss or weight loss) are present, a colonoscopy has been performed and was negative for other causes. 4. women in fertile age (\<55 years old) must use contraception or be postmenopausal for at least two years. 5. average worst abdominal pain score (on 11-point nrs) of \> 3, during the two-week run-in period. exclusion criteria: 1. insufficient fluency of the dutch language; 2. any previous use (also incidental use) of peppermint oil capsules in the last 3 months prior to inclusion (the use of peppermint tea, menthol candy etc. is allowed); 3. the inability to stop regular use of medication affecting the gastro-intestinal system (such as non steroidal anti inflammatory drugs (nsaid), laxatives, prokinetics, opioids, smasmolytics and anti-diarrhoeal drugs). this use should be halted at least 1 week before enrollment into the run-in period; 1. the use of 1 antidepressant drug is allowed, providing dosing has been stable for \> 6 weeks before enrollment; 2. the use of 1 proton pump inhibitor (ppi) is allowed, providing dosing has been stable \> 6 weeks before enrollment; 4. previous major abdominal surgery or radiotherapy interfering with gastrointestinal function: 1. uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months; 2. other surgery upon judgment of the principle investigator; 5. history of liver disease, cholangitis, achlorhydria, gallstones or other diseases of the gallbladder/biliary system; 6. pregnancy, lactation; 7. using drugs of abuse; 8. known allergic reaction to peppermint.

Keywords: irritable bowel syndrome abdominal pain targeted delivery peppermint oil